—#215660

Product

Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting Tool features two curved, insulated jaws with heating elements that operate through heat and pressure rather than radiofrequency energy.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K251238
Affected lot / code info: Model No. C-VH-6000; UDI: 00607567701274; Lot/Serial No. 3000486429, 3000487231, 3000487726, 3000488639.

Why it was recalled

Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Getinge Field Representatives contacted impacted accounts by telephone on 8/6/25 to notify them of this recall action and provide instructions for quarantine and return of affected devices. Consignees were asked to stop all visual inspection and return all HemoPro 3 units. Returns can be coordinated by calling or emailing Michele Kanis for an RMA at michele.kanis@getinge.com or (408)635-0647. Consignees are to utilize HemoPro 2 in place of HemoPro 3 units. Getinge Field Representatives delivered an updated URGENT MEDICAL DEVICE RECALL notice starting on 10/6/25 dated October 2025. The written notification is a supplement to the verbal notification made previously.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: US Nationwide distribution in the states of FL, IL, MD & TX.

Timeline

Recall initiated: 2025-08-06
Posted by FDA: 2025-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215660. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.